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Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

Sponsored by Bristol-Myers Squibb

About this study

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Where this study is enrolling (23)

  • Inglewood Clinical

    Los Angeles, California

    Call 706-863-9595

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  • Stanford Neuroscience Health Center

    Palo Alto, California

    Call 000-000-0000

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  • Irvine Clinical Research

    Irvine, California

    Call 949-753-1663

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  • Fullerton Neurology and Headache Center

    Fullerton, California

    Call 714-381-0801

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  • Research of the Rockies

    Colorado Springs, Colorado

    Call 303-715-9024

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Show all 23 locations

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida

    Call 239-939-7777

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  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida

    Call 813-974-4355

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  • Intercoastal Medical Group

    Sarasota, Florida

    Call 941-203-3750

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  • Jacksonville Center for Clinical Research

    Jacksonville, Florida

    Call 904-673-1252

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  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, Florida

    Call 407-426-9299

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  • Alzheimer's Research and Treatment Center

    Wellington, Florida

    Call 561-209-2400

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  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois

    I'm interested

  • Southern Illinois University School of Medicine

    Springfield, Illinois

    Call 217-545-7197

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  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana

    Call 317-537-6088

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  • QUEST Research Institute

    Farmington Hills, Michigan

    Call 248-957-8940

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  • Private Practice - Dr. Ronald Louis Schwartz

    Hattiesburg, Mississippi

    Call 601-606-0911

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  • Advanced Clinical Institute

    West Long Branch, New Jersey

    Call 732-807-4700

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  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey

    Call 973-850-4622

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  • Neurological Associates Albany

    Albany, New York

    Call 518-426-0575

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  • Dent Neurosciences Research Center, Inc

    Amherst, New York

    Call 716-250-2000

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  • University at Buffalo - UBMD Neurology

    Buffalo, New York

    Call 281-630-2316

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  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania

    Call 610-277-8073

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  • Central Texas Neurology Consultants, PA

    Round Rock, Texas

    Call 443-852-2085

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Who can participate

Inclusion criteria

  • ✓Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
  • ✓Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
  • ✓Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
  • ✓Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.

Exclusion criteria

  • ✕Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia.
  • ✕Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
  • ✕Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
  • ✕Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.
  • ✕Other protocol-defined Inclusion/Exclusion criteria apply.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.